Nod to human trial marks ‘beginning of the end’, says govt


The approval for human trails for two made-in-India COVID-19 vaccines, marks the ‘beginning of the end,’ the government said today. Two COVID-19 vaccine candidates — Covaxin, developed by the Hyderabad-based Bharat Biotech International Limited in collaboration with the ICMR and the National Institute of Virology (NIV) and ZyCov-D vaccine by Zydus Cadila — had recently got the nod for human clinical trials from the Drug Controller General of India. Both have been approved for Phase II, III trials.

“The nod given by the Drug Controller General of India CDSCO (The Central Drugs Standard Control Organisation) for the conduct of the human trial for the vaccines, marks the beginning of the end,” a letter by the ministry of science and technology mentioned.

More than 140 candidate vaccines to cure COVID-19 infection, are under various stages of development. Out of them, 11 vaccine candidates including the two Indian vaccine candidates, have entered the human trial phase.

One of the leading candidates is AZD1222 developed Jenner Institute of University of Oxford and licenced to AstraZeneca British-Swedish multinational pharmaceutical and bio-pharmaceutical company headquartered in Cambridge, England. The MRNA-1273 vaccine developed by Kaiser Permanente Washington Health Research Institute, Washington and taken up for production by the US-based Moderna pharmaceutical is just a step behind. “Both these firms have already inked an agreement with Indian manufacturers for production of the COVID vaccines,” the government said.

Citing India’s role in global efforts to develop the vaccine, the ministry said, “In the past years, India has emerged as one of the significant vaccine manufacturing hubs. Indian manufacturers account for 60% of vaccine supplies made to UNICEF.”

“The vaccine for novel coronavirus may be developed anywhere in the world, but without Indian manufacturers involved the production of required quantity is not going to be feasible,” it added.

Several institutions have also engaged in R&D for the development of vaccines in India. “With the primary scientific inputs coming from institutions like Pune based ICMR institution National Institute of Virology and Hyderabad based CSIR institution Center for Cellular and Molecular Biology, six Indian companies are working on a vaccine for COVID-19,” the ministry mentioned in a letter.

How these vaccines work:

“We can inactivate a whole virus with heat or formaldehyde (that is ‘killed’), yet keep the antigen molecular structures still intact. However, the inactivated virus will not be able to infect or cause disease, as it is no longer functional,” the letter read.

“The Bharat Biotech’s Covaxin uses the virus isolated from an Indian patient by the National Institute of Virology to develop the inactivated virus vaccine,” the ministry said.

Bharat Biotech has earlier developed vaccines against polio, rotavirus, Japanese encephalitis and Zika, according to the statement.

After medical experts had cautioned against rushing a COVID-19 vaccine, the ICMR on Saturday said, “The aim is to complete these phases at the earliest, so that population-based trials for efficacy could be initiated without delay.”

The ICMR said the letter by its director general Dr Balram Bhargava to principal investigators of the clinical trial sites, was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.

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Nod to human trial marks ‘beginning of the end’, says govt
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